CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
CCH-aaes +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04677712
NCT04677712Phase 4Completed
CompareCT.gov

MOBI: A Phase 4, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite in Adult Females

Endo Pharmaceuticals·interventional·Posted Dec 21, 2020·Updated Aug 21, 2023

In Brief

A Phase 4 clinical trial evaluating CCH-aaes, Compression, and 4 other interventions for Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite. Completed, enrolled 48 participants across 8 sites.

Detailed Summary

This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum \[CCH\]-aaes) treatment of cellulite in the buttocks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdematous Fibrosclerotic Panniculopathy (EFP), Cellulite
CountriesUnited States
CollaboratorsDeNova Research, University of California, San Diego, The Wall Center for Plastic Surgery, Mathew Avram, MD, Laser & Skin Surgery Medical Group, Inc., Investigate MD, LLC, Biesman, Brian, M.D., Plastic Surgical Associates of Fort Collins, P.C.

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedDec 21, 2020
Enrollment StartDec 28, 2020
Primary CompletionJun 26, 2021
Study CompletionSep 2, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.5 years ago

Interventions

CCH-aaesdrug

Participants were administered CCH-aaes by subcutaneous injection to both buttocks.

Compressionother

Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.

Cold Packsother

Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.

Arnica Geldrug

Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.

INhance®drug

Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.

PDLother

Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.